Background of Different Phenotypes of Coeliac Disease

NCT05597904 | Recruiting

• 1 other identifier: R22088
• Study Type: observational
• Target: 3,500
• Locations: 1 country
• Sites: 1

Brief Summary

The main purpose of this study is to investigate genetic, serological, immunological and microbiata diversities between different coeliac disease phenotypes and to discover applicable prognostic markers for specific phenotypes.

Conditions

Celiac Disease; Dermatitis Herpetiformis

Keywords

coeliac disease; dermatitis herpetiformis; gluten-free diet; transglutaminase; microbiata

Outcome Measures

Primary Outcomes (1)

• Non-HLA variant association

  phenotype specific non-HLA variants

  baseline

Secondary Outcomes (5)

• serum transglutaminase antibodies

  baseline

• microbiata

  baseline

• quality of life measure

  baseline

• gastrointestinal symptoms

  baseline

• dietary adherence

  baseline

Study Arms (2)

Coeliac disease patients

Adult (18 years or over) patients with previous coeliac disease or dermatitis herpetiformis diagnosis

Genetic: Genetic predisposition

Healthy controls

500 adult (18 years or over) friends or non-related family members of coeliac disease or dermatitis herpetiformis patients participating in the study, no previous coeliac disease or dermatitis herpetiformis diagnosis. In addition 1000 controls will be included from Biobank

Genetic: Genetic predisposition

Interventions

Genetic predisposition GENETIC

Assessment of genetic predisposition to various celiac disease phenotypes. No intervention.

Coeliac disease patients; Healthy controls

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

National and also focused recruitment for patients with coeliac disease or dermatitis herpetiformis diagnosis. Healthy controls recruited via volunteered subjects with coeliac disease or dermatitis herpetiformis

You may qualify if:

• Cohorts 1 and 2: coeliac disease or dermatitis herpetiformis diagnosis
• Cohort 3: friend or non-related family member of coeliac disease or dermatitis herpetiformis patient

You may not qualify if:

• Cohorts 1-3: Age \<18 years
• Cohorts 1 and 2: coeliac disease or dermatitis herpetiformis diagnosis not confirmed
• Cohort 3: coeliac disease or dermatitis herpetiformis diagnosis

Sponsors & Collaborators

• Tampere University Hospital: lead
• Tampere University: collaborator
• University of Helsinki: collaborator
• University of Turku: collaborator
• Oulu University Hospital: collaborator
• University of Debrecen: collaborator
• University of Trieste: collaborator
• Oslo University Hospital: collaborator

Study Sites (1)

Tampere University Hospital

Tampere, 33521, Finland

RECRUITING

MeSH Terms

Conditions

Celiac Disease; Dermatitis Herpetiformis

Interventions

Genetic Testing

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Vesiculobullous; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Genetic Techniques; Genetic Services; Health Services; Health Care Facilities Workforce and Services; Diagnostic Services; Preventive Health Services

Central Study Contacts

Teea T Salmi, Prof

CONTACT

+358503016355; teea.salmi@pshp.fi

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Dermatology

Study Record Dates

• First Submitted: October 3, 2022
• First Posted: October 28, 2022
• Study Start: November 8, 2022
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2030
• Last Updated: September 17, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)